Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT00547105

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-25
• Study Completion Date: 2017-07-06

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with stereotactic body radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic body radiation therapy works in treating patients with locally advanced or metastatic non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the effect of erlotinib and stereotactic body radiotherapy on 6-month progression-free survival of patients with locally advanced or metastatic non-small cell lung cancer.

Secondary

• To describe the actuarial rate of in-field local control and out-of-field disease progression in patients treated with this regimen.
• To evaluate the safety of this regimen in these patients.
• To evaluate overall survival of patients treated with this regimen.
• To evaluate the duration of erlotinib usage and time to initiation of third-line systemic therapy (chemotherapy or biologic agent) in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. Beginning 1-4 weeks after the initiation of erlotinib hydrochloride, patients undergo stereotactic body radiotherapy.

After completion of study treatment, patients are followed every 3 months.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

erlotinib in combination with SBRT

Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

SBRT

Intervention Type: RADIATION

SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body

Interventions

Erlotinib

Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Intervention Type: DRUG

SBRT

SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body

Intervention Type: RADIATION

Other Intervention Names

Tarceva; stereotactic body radiation therapy

Eligibility Criteria

Inclusion Criteria

1. Patients must have biopsy proven NSCLC that is locally advanced or metastatic.

2. Patients must have had failure of at least one prior chemotherapy regimen.

3. Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.

4. Age ≥ 18 years

5. Patients must have measurable disease at baseline.

6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT.

1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months

2. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.

3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).

4. Up to 2 contiguous vertebral metastases will be considered a single site of disease.

7. Patients must have a KPS >60

8. AST, ALT & Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.

9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.

10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).

11. Females of childbearing potential should have a negative pregnancy test.

12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.

13. Patients must provide verbal and written informed consent to participate in the study.

14. Total bilirubin: within normal institutional limits

Exclusion Criteria

1. Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.

2. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible

3. Patients with serious, uncontrolled, concurrent infection(s).

4. Significant weight loss (>10%) in the prior 3 months.

5. Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.

6. Patients with cutaneous metastasis of NSCLC.

7. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.

8. Patients with more than 6 discrete extra-cranial lesions.

9. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.

10. Unwillingness to participate or inability to comply with the protocol for the duration of the study.

11. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.

12. Patients who have had prior EGFR inhibitors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D. Timmerman, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

SCCC-042007-003

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000571634

Identifier Type: REGISTRY

Identifier Source: secondary_id

SCCC-0609131

Identifier Type: -

Identifier Source: org_study_id